A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight

Myopia Clinical Trial

Official title:

A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693260
• Other study ID #: EYEQUE - 007
• Status: Completed
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: September 10, 2021

Study information

• Verified date: August 2022
• Source: EyeQue Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.

Description:

A prospective exploratory study to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

1. Male or Female

2. Ages =>7 y.o.

3. Subjects that are minors (<18 years old) must have a parent or legal guardian.

4. Binocular vision

5. Willing and able to give informed consent and follow all study procedures and requirements

6. Fluent in English

7. Be treated for myopia with Ortho-K, day contacts, or night contacts

Exclusion Criteria:

1. Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.

2. Has traveled outside the country within the last 4 weeks

3. Medications:

a. Taking medications that may affect ability to follow instructions.

4. Eye Disease:

a. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection, keratoconus, etc.

5. Subjects that:

1. Lack physical dexterity to properly operate the EyeQue App on the smartphone

2. Lack the ability to follow instruction

3. Lack binocular vision

4. Lack the ability to maintain both eyes open

5. Had eye surgery within the last 12 months (including Lasik)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Visual Acuity with a Hand-held Device Supported by Mobile App.
The Insight will be compared to a standard ETDRS eyechart

Locations

Country	Name	City	State
United States	Eye Boutique Optometry	Santa Clara	California

Sponsors (2)

Lead Sponsor	Collaborator
EyeQue Corp.	Eye Boutique Optometry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Departure from scheduled follow-up visits with clinical confirmation	Site will monitor the patient remotely and determine if the subject should depart from their scheduled visits based on at-home testing. If visit departure is warranted the site will examine them in the office and confirm if a departure from normally schedule visit was warranted.	Approximately 21 Weeks
Secondary	Measure rapidly changing visual acuity	Ability to track and measure visual acuity with the EyeQue Insight in patients with rapidly changing visual acuity during the first month of Ortho-K introduction.	Approximately 21 Weeks